BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 250 ML

    MDR report key: 5368242 · Received January 14, 2016

    Report

    Report Number
    3005290010-2016-00038
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 2, 2015
    Report Date
    January 8, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD A BREAK IN A CRYOMACS FREEZING BAG 250 ML DURING THAWING. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26497 CRYOMACS FREEZING BAG 250 ML CRYOMACS FREEZING BAG 250 ML OVG MILTENYI BIOTEC GMBH 6140822002

    Patients

    Seq Age Sex Outcome Treatment
    1